Pancreatic CancerPhase 2NCT06435260
Hypofractionated Radiotherapy +Chemotherapy+ Camrelizumab as Neoadjuvant Therapy for Pancreatic Cancer
A Phase 2 study testing Camrelizumab+chemotherapy and hypofractionated radiotherapy in people with Pancreatic Cancer, run by Hebei Medical University Fourth Hospital at 1 site in China.
Trial summary
The purpose of this study is to assess surgical conversion rate and the immediate and long-term outcomes to patients who receive hypofractionated radiotherapy and AG combined with camrelizumab immunotherapy of Borderline Resectable/locally advanced pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Camrelizumab+chemotherapy and hypofractionated radiotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2024to 1 Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age:18 to 75 years old, male or female;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- Tumor was located in the pancreas;
- Pathological diagnosis was pancreatic ductal adenocarcinoma or acinar cell carcinoma;
- No distant metastasis;
- The pancreatic tumor is located more than 1cm away from the duodenum；
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- Clinical assessment was locally advanced or critical for resectable.
- Locally advanced pancreatic cancer diagnostic criteria: (1) due to tumor invasion, venous occlusion or involving a wide range of superior mesenteric vein branch of jejunum, cannot safely - superior mesenteric vein reconstruction. ② (pancreatic head/uncinate process tumors) tumor contact with superior mesenteric artery or celiac artery > 180°. Tumor contact with superior mesenteric artery or coeliac trunk artery > 180°, tumor contact with coeliac trunk artery and invasion of abdominal aorta.
- Critical for resectable pancreatic cancer diagnostic criteria: (1) contact with portal vein tumor - superior mesenteric vein > 180 °, 180 ° or less or contact combined intravenous contour irregular or venous thrombosis, but safety is complete resection and reconstruction; The tumor contacted the inferior vena cava. ② (pancreatic head/uncinate process tumors) the tumors contacting the common hepatic artery, but not involving the celiac artery or the origin of the left and right hepatic arteries, can be completely resected and safely reconstructed; Superior mesenteric artery tumor contact 180 ° or less; The tumor contacts the aberrant arteries (such as accessory right hepatic artery, alternative right hepatic artery, alternative common hepatic artery, etc.). (pancreatic body and tail tumors) tumor contact with superior mesenteric artery ≤180°; Tumor contact with celiac artery ≤180°; 7.There was no history of immune system diseases, other malignant tumors, myocarditis, coronary heart disease, other cardiovascular and cerebrovascular diseases, thyroid dysfunction, liver and kidney diseases, psychiatric diseases, infectious diseases, or systemic diseases other than those mentioned above.
- Participants were willing to join in this study, good adherence and written informed consent.
Who cannot join
- Patients who did not meet these inclusion criteria;
- Poor cognitive ability, inability to answer questions, inability to fill out questionnaires, or mental disorders;
- The investigators think inappropriate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050011
Li Peng, 13933868818, pengli72@sina.com
Li Peng
About this study
Official title: To Explore the Efficacy of Hypofractionated Radiotherapy Followed by AG Regimen Chemotherapy Plus Camrelizumab Immunotherapy as Neoadjuvant Therapy for Borderline Resectable/Locally Advanced Pancreatic Cancer
The purpose of this study is to assess surgical conversion rate and the immediate and long-term outcomes to patients who receive hypofractionated radiotherapy and AG combined with camrelizumab immunotherapy of Borderline Resectable/locally advanced pancreatic cancer.
- Conditions
- Pancreatic Cancer
- Being tested
- Camrelizumab+chemotherapy, hypofractionated radiotherapy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Camrelizumab+chemotherapyDrug
Chemotherapy combined with ICIs was started 5-7 days after the completion of radiotherapy:
AG: intravenous nab-paclitaxel 125 mg/m2 and gemcitabine 1000mg/m2 d1,8, q3w, 4 cycles.
Camrelizumab: 200mg, iv, 30min, q3w, 4 cycles.
hypofractionated radiotherapyRadiation
Hypofractionated radiotherapy:PGTV=30Gy/5F(PTV≥25Gy/5F),
| Study group | Role | What they receive |
|---|---|---|
| Hypofractionated radiotherapy+Camrelizumab+chemotherapy | Experimental | The patients with Borderline Resectable/locally advanced pancreatic cancer were treated with hypofractionated radiotherapy using the CyberKnife radiotherapy machine, which was as follows: PGTV=30Gy/5F(PTV≥25Gy/5F), 1 day, a total of 5 days; Chemotherapy combined with ICIs was started 5-7 days after the end of radiotherapy. The chemotherapy regimen was AG regimen (albumin paclitaxel 125mg/m2 d1,8 + gemcitabine 1000mg/m2 d1,8 q3w). The ICIs regimen consisted of 4 cycles of camrelizumab 200mg q21d (on the first day of each cycle). The efficacy was evaluated within 2 weeks after the end of the above-mentioned neoadjuvant therapy, and surgical treatment was performed for patients who were evaluated as operable and those who had a clear willingness to undergo surgery. After surgery, adjuvant chemotherapy and ICIs of the original scheme were determined according to the patient's tolerance and independent willingness, and then the clinical follow-up period was entered. Receives: Drug: Camrelizumab+chemotherapy; Radiation: hypofractionated radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
a.R0-resection rate
The tumor was completely removed during surgery, and the cutting margins were also negative when viewed microscopically
Measured: One week after surgery
Secondary outcomes (8)
Surgical conversion rate
Tumors that were otherwise unresectable were transformed into surgically resectable tumors.
Measured: 2 to 4 weeks after neoadjuvant therapy
Tumor regression rate
Degree of tumor response to neoadjuvant therapy
Measured: One week after surgery
Objective response rate (ORR)
It refers to the proportion of patients who achieve a prespecified reduction in tumor volume (CR/PR) and maintain the minimum time requirements according to accepted response evaluation criteria (e.g., RECIST in solid tumors, version 1.1).
Measured: through study completion，an average of 3 year
Disease control rate (DCR)
It refers to the proportion of patients who achieve a prespecified reduction in tumor volume (CR/PR/SD) and maintain the minimum time requirements according to accepted response evaluation criteria (e.g., RECIST in solid tumors, version 1.1).
Measured: through study completion，an average of 3 year
3-year Overall survival (OS)
The time between the start of randomization and death from any cause
Measured: Three years from enrollment
3-year Event Free Survival (EFS)
The time from randomization until disease progression, treatment discontinuation for any cause, or death.
Measured: Three years from enrollment
Adverse events
Toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. The number of participants with adverse events will be recorded at each treatment visit.
Measured: From enrollment to the end of treatment at 8 weeks
Quality of life scores
Evaluate the quality of life according to The World Health Organization quality of life (WHOQOL) -BREF. The minimum value is 1, the maximum value is 5. And higher scores mean a better outcome. The number of participants with quality of life will be recorded at each treatment visit.
Measured: 1 years after therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start1 Aug 2024
- Primary completion1 Jun 2025
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Hebei Medical University Fourth HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University Fourth Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li Peng, Principal investigator, Fourth Hospital of Hebei MedicalFengpeng Wu, Principal investigator, Fourth Hospital of Hebei Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06435260
- Sponsor's protocol ID
- ARK-pancreatic-001
- Status last verified
- Jun 2026
- First submitted
- 24 May 2024
- Last updated
- 6 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Explore the Efficacy of Hypofractionated Radiotherapy Followed by AG Regimen Chemotherapy Plus Camrelizumab Immunotherapy as Neoadjuvant Therapy for Borderline Resectable/Locally Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT06435260
- Acronym / sponsor ID
- ARK-pancreatic-001
- Conditions
- Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hebei Medical University Fourth HospitalUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 30 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess surgical conversion rate and the immediate and long-term outcomes to patients who receive hypofractionated radiotherapy and AG combined with camrelizumab immunotherapy of Borderline Resectable/locally advanced pancreatic cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypofractionated radiotherapy+Camrelizumab+chemotherapy | Experimental | Drug: Camrelizumab+chemotherapy, Radiation: hypofractionated radiotherapyThe patients with Borderline Resectable/locally advanced pancreatic cancer were treated with hypofractionated radiotherapy using the CyberKnife radiotherapy machine, which was as follows: PGTV=30Gy/5F(PTV≥25Gy/5F), 1 day, a total of 5 days; Chemotherapy combined with ICIs was started 5-7 days after the end of radiotherapy. The chemotherapy regimen was AG regimen (albumin paclitaxel 125mg/m2 d1,8 + gemcitabine 1000mg/m2 d1,8 q3w). The ICIs regimen consisted of 4 cycles of camrelizumab 200mg q21d (on the first day of each cycle). The efficacy was evaluated within 2 weeks after the end of the above-mentioned neoadjuvant therapy, and surgical treatment was performed for patients who were evaluated as operable and those who had a clear willingness to undergo surgery. After surgery, adjuvant chemotherapy and ICIs of the original scheme were determined according to the patient's tolerance and independent willingness, and then the clinical follow-up period was entered. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age:18 to 75 years old, male or female;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- Tumor was located in the pancreas;
- Pathological diagnosis was pancreatic ductal adenocarcinoma or acinar cell carcinoma;
- No distant metastasis;
Key exclusion criteria (3 listed)
- Patients who did not meet these inclusion criteria;
- Poor cognitive ability, inability to answer questions, inability to fill out questionnaires, or mental disorders;
- The investigators think inappropriate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Camrelizumab+chemotherapyChemotherapy combined with ICIs was started 5-7 days after the completion of radiotherapy: AG: intravenous nab-paclitaxel 125 mg/m2 and gemcitabine 1000mg/m2 d1,8, q3w, 4 cycles. Camrelizumab: 200mg, iv, 30min, q3w, 4 cycles. | Drug | Hypofractionated radiotherapy+Camrelizumab+chemotherapy |
| hypofractionated radiotherapyHypofractionated radiotherapy:PGTV=30Gy/5F(PTV≥25Gy/5F), | Radiation | Hypofractionated radiotherapy+Camrelizumab+chemotherapy |
Primary outcome
a.R0-resection rate
Time frame: One week after surgery
The tumor was completely removed during surgery, and the cutting margins were also negative when viewed microscopically
8 secondary outcomes
Surgical conversion rate
Time frame: 2 to 4 weeks after neoadjuvant therapy
Tumor regression rate
Time frame: One week after surgery
Objective response rate (ORR)
Time frame: through study completion，an average of 3 year
Disease control rate (DCR)
Time frame: through study completion，an average of 3 year
3-year Overall survival (OS)
Time frame: Three years from enrollment
3-year Event Free Survival (EFS)
Time frame: Three years from enrollment
Adverse events
Time frame: From enrollment to the end of treatment at 8 weeks
Quality of life scores
Time frame: 1 years after therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Li Peng principal investigator
Fourth Hospital of Hebei Medical
Fengpeng Wu principal investigator
Fourth Hospital of Hebei Medical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Camrelizumab+chemotherapy and hypofractionated radiotherapy in people with Pancreatic Cancer, run by Hebei Medical University Fourth Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Li Peng (13933868818, pengli72@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
a.R0-resection rate (time frame: One week after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.